# FDA recall Z-1139-2024

> **BioFire Diagnostics, LLC** · Class II · device recall initiated 2024-01-26.

## Product

BIOFIRE Blood Culture Identification 2 (BCID2) Panel    when used with:  BD BACTEC Lytic Anaerobic medium  BD BACTEC Peds Plus medium  BD BACTEC Plus Aerobic medium  BD BACTEC Plus Anaerobic medium  BD BACTEC Standard Aerobic medium  BD BACTEC Standard Anaerobic medium    The BIOFIRE Blood Culture Identification 2 (BCID2) Panel is a multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.

## Reason for recall

Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums

## Distribution

Worldwide - U.S. Nationwide distribution including in the states of  AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Andorra, United Arab Emirates, Armenia, Argentina, Austria, Australia, Bosnia, Belgium, Bulgaria, Bahrain, Brunei, Bolivia, Brazil, Canada, Switzerland, Cote D'Ivoire, Chile, China, Colombia, Costa Rica, Cyprus, Cech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, France, Gabon, United Kingdom, Georgia, Guadeloupe, Greece, Guatemala, Hong Kong, Honduras, Croatia, Hungary, Iceland, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, Korea, Kuwait, Lebanon, Lithuania, Latvia, Morocco, Macedonia, Mali, Mongolia, Macau, Mexico, Malaysia, New Caledonia, Nigeria, Nicaragua, Netherlands, Norway, New Zealand, Oman, Panama, Peru, Fre

## Key facts

- **Recall number:** Z-1139-2024
- **Recalling firm:** BioFire Diagnostics, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-26
- **Report date:** 2024-02-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Salt Lake City, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1139-2024

## Citation

> AI Analytics. FDA recall Z-1139-2024. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1139-2024. Source: US FDA. Licensed CC0.

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